The Manager, Medical Information will assist in the operational oversight of Medical Information within the Medical Affairs function. The manager will be responsible for providing and supporting the provision of accurate, scientifically balanced and timely responses to inquiries received from health care professionals, consumers and other customers. This role will also be active in the medical content review for promotional and medical materials intended for training and/or external distribution. The manager will monitor the scientific literature and communicate new data to relevant internal groups. Candidates applying for this position must have the ability to take initiative and work independently requiring minimal supervision.
This is a hybrid onsite role based out of our Waltham, MA office.
Responsibilities:
Provide accurate, balanced and timely medical and scientific information to internal and external customers such as health care professionals, consumers and other customers
As a part of the Medical/Legal/Regulatory review and approval process, participate as a medical reviewer for accuracy, content containing promotional and/or medical and scientific content intended for internal and external customers (e.g., communications Q&A material, dear health care provider letters, documents for public comment, etc)
Apply knowledge of business strategy and inquiry activity to identify business needs, trends and emerging issues, raising awareness with appropriate Alkermes colleagues.
Contribute to departmental/organization efforts to support new product launch preparation and activities
Support call center operations specific to therapy area and assigned responsibilities
Independently research and write medical response documents (Standard Response Letters, Medicaid Submission Documents, AMCP Dossier,), create unique responses and proactively update existing response documents on an ongoing basis; obtain approval for use to ensure compliance with existing regulations, policies and procedures; train others (call center, medical affairs, medical science directors) on their content and use
Perform quality monitoring of inquiry handling, ensure identification and reporting of potential adverse events and product complaints and are triaged accordingly to PV and QA
Proactively monitor the literature for new scientific information; identify relevant publications, analyze and communicate information of interest internally Work with internal and external legal counsel to ensure compliance with company policies and procedures
Provide medical and scientific input and contribute to assigned product and project teams
Collaborate closely with members of other internal groups (e.g., Regulatory, Marketing, Sales, Legal, Clinical R&D) as needed
Provide information and support for business activities such as relevant insights, knowledge of product data, etc.
Attend scientific conferences to provide medical support and to staff medical information booth as assigned
Lead pre-conference Medical Affairs/Medical Information activities
Develop post-conference reviews and reports for internal stakeholders
Assist in the mentorship and training of newly hired staff in Medical Information, Medical Affairs, and other key internal colleagues including but not limited to interns and contractors.
